Sec. 3093. ENCOURAGING VACCINE INNOVATION
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## SEC. 3093 ENCOURAGING VACCINE INNOVATION **[**[42 U.S.C. 300aa-2 note](/us/usc/t42/s300aa-2)**]** ###
(a)Vaccine Meetings The Director of the Centers for Disease Control and Prevention shall ensure that appropriate staff within the relevant centers and divisions of the Office of Infectious Diseases, and others, as appropriate, coordinate with respect to the public health needs, epidemiology, and program planning and implementation considerations related to immunization, including with regard to meetings with stakeholders related to such topics. ###
(b)Report on Vaccine Innovation ####
(1)In general Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this section as the “Secretary”), in collaboration with appropriate agencies or offices within the Department of Health and Human Services, including the National Institutes of Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, and the Biomedical Advanced Research and Development Authority, shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives, and post publicly on the Internet website of the Department of Health and Human Services, a report on ways to promote innovation in the development of vaccines that minimize the burden of infectious disease. ####
(2)Contents The report described in paragraph
(1)shall review the current status of vaccine development and, as appropriate— #####
(A)consider the optimal process to determine which vaccines would be beneficial to public health and how information on such vaccines is disseminated to key stakeholders; #####
(B)examine and identify whether obstacles exist that inhibit the development of beneficial vaccines; and #####
(C)make recommendations about how best to remove any obstacles identified under subparagraph
(B)in order to promote and incentivize vaccine innovation and development. ####
(3)Consultation In preparing the report under this subsection, the Secretary may consult with— #####
(A)representatives of relevant Federal agencies and departments, including the Department of Defense and the Department of Veterans Affairs; #####
(B)academic researchers; #####
(C)developers and manufacturers of vaccines; #####
(D)medical and public health practitioners; #####
(E)representatives of patient, policy, and advocacy organizations; and #####
(F)representatives of other entities, as the Secretary determines appropriate. ###
(c)Updates Related to Maternal Immunization ####
(1)Additional vaccines Section 2114(e) of the Public Health Service Act (42 U.S.C. 300aa-14(e)) is amended by adding at the end the following: > > #### “(3) Vaccines recommended for use in pregnant women > > The Secretary shall revise the Vaccine Injury Table included in subsection (a), through the process described in subsection (c), to include vaccines recommended by the Centers for Disease Control and Prevention for routine administration in pregnant women and the information described in subparagraphs
(B)and
(C)of paragraph
(2)with respect to such vaccines.” > . ####
(2)Petition content Section 2111 of the Public Health Service Act (42 U.S.C. 300aa-11) is amended by adding at the end the following: > > ### “(f) Maternal Immunization > > > #### “(1) In general > > Notwithstanding any other provision of law, for purposes of this subtitle, both a woman who received a covered vaccine while pregnant and any child who was in utero at the time such woman received the vaccine shall be considered persons to whom the covered vaccine was administered and persons who received the covered vaccine. > > > #### “(2) Definition > > As used in this subsection, the term ‘child’ shall have the meaning given that term by subsections
(a)and
(b)of section 8 of title 1, United States Code, except that, for purposes of this subsection, such section 8 shall be applied as if the term ‘include’ in subsection
(a)of such section were replaced with the term ‘mean’.” > . ####
(3)Petitioners Section 2111(b)(2) of the Public Health Service Act (42 U.S.C. 300aa-11(b)(2)) is amended by adding “A covered vaccine administered to a pregnant woman shall constitute more than one administration, one to the mother and one to each child (as such term is defined in subsection (f)(2)) who was in utero at the time such woman was administered the vaccine.” at the end. ## Subtitle J Technical Corrections
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